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| ID | Type | Description | Link |
|---|---|---|---|
| 25JAR817 | Other Identifier | DH Cancer Center |
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This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aPBI Re-irradiation | Experimental | Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy and have received or are receiving re-irradiation for in-breast recurrence of breast cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reirradiation | Radiation | aPBI, which is routinely used to treat patients who have previously not been irradiated, with a dose of 30 Gy in 5 fractions using a VMAT technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment-associated toxicity | Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI. | Within 1 year |
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Inclusion Criteria
Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
Patients must have received prior radiotherapy to the breast
Patients must have an intact, involved breast.
Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
Patients must have a lumpectomy cavity that can be delineated on CT scan.
Patients who are able to provide informed consent.
Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.
Exclusion Criteria
Patients who meet any of the criteria below may NOT participate in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D000069475 | Re-Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019233 | Retreatment |
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This is a prospective, single-arm, phase I/II clinical trial. The study will be conducted in two stages. We plan to enroll the first 11 participants into the phase 1 portion of the trial and follow them for toxicities for 1 year. Once toxicity assessment is complete and safety is determined, an additional 22 participants
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